Integrated disposable for automatic or manual blood dosing

ABSTRACT

An integrated sampling device defines a first opening and a second opening. The first opening is connected to a channel for drawing fluid automatically towards a test media upon incision by an incision portion. The second opening is positioned over the test media allowing manual sampling of fluid if the channel fails to draw a sufficient amount of fluid onto the test media.

CROSS REFERENCE TO RELATED APPLICATION

This application is a divisional of U.S. patent application Ser. No.11/950,457 filed Dec. 5, 2007, which is a continuation of U.S. patentapplication Ser. No. 10/840,931 filed May 7, 2004, now U.S. Pat. No.7,322,943, issued Jan. 29, 2008, which are hereby incorporated byreference in their entirety.

BACKGROUND

The present invention generally relates to lancets used in bodily fluidsampling devices and more particularly, but not exclusively, to anintegrated sampling device that contains multiple openings to allowfluid to be automatically or manually sampled.

A variety of body fluid sampling devices, such as blood glucose meters,have been developed to form an incision and to analyze body fluid fromthe incision. In one type of device, a lancet is used to form anincision, and after forming the incision, the user manually places atest strip against the skin in order to draw a fluid sample into thetest strip. Sometimes the fluid drawn onto the test strip is not enoughto generate accurate test results. Coagulation of blood or other fluidsin the test strip can prevent further dosing of the test strip. Whenthis occurs, the user has to discard the test strip and either try tocollect additional fluid from the same incision onto a new test strip orform a second incision so as to repeat the process. As should beappreciated, this can be both wasteful and painful. Although test stripshave been developed to test the sufficiency in the amount of the bodyfluid drawn, the sufficiency test occurs after the test strip draws thefluid, which is too late, because the test strip still has to bediscarded.

Thus, there is need for further contribution in this area of technology.

SUMMARY

One aspect of the present invention concerns an integrated samplingdevice for analyzing body fluid. The device includes a sampling portionthat defines a channel with a first opening. A test media is positionedalong the channel for analyzing the body fluid. The sampling portiondefines a second opening that is positioned closer to the test mediathan the first opening for dosing the body fluid onto the test media viathe second opening when dosing of the body fluid via the first openingis unsuccessful.

Another aspect concerns a method in which body fluid is drawn into afirst opening of a sampling device. The sampling device includes achannel to transport the body fluid onto test media. The body fluiddrawn into the first opening is determined to be insufficient. The bodyfluid is collected with a second opening of the sampling device that ispositioned closer to the test media than the first opening.

A further aspect concerns an integrated sampling device that includesmeans for forming an incision in skin and means for collecting bodyfluid automatically from the incision. The device further includes meansfor collecting the body fluid manually from the incision upon failure tocollect the body fluid automatically, and means for analyzing the bodyfluid that is collected.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a front view of an integrated sampling device according to oneembodiment of the present invention.

FIG. 2 is a rear view of the integrated sampling device depicted in FIG.1.

FIG. 3 is an enlarged end view of the integrated sampling deviceillustrated in FIG. 1.

FIG. 4 shows fluid being sampled through the first opening of the FIG. 1integrated sampling device.

FIG. 5 shows the FIG. 1 integrated sampling device sampling fluidthrough the second opening.

FIG. 6 is a front view of an integrated sampling device according toanother embodiment.

FIG. 7 is a diagrammatic view of a tape cassette storing the integratedsampling devices according to FIG. 1.

DESCRIPTION OF THE SELECTED EMBODIMENTS

For the purposes of promoting an understanding of the principles of theinvention, reference will now be made to the embodiments illustrated inthe drawings and specific language will be used to describe the same. Itwill nevertheless be understood that no limitation of the scope of theinvention is thereby intended. Any such alterations, modifications, andfurther applications of the principles of the present invention asillustrated are contemplated as would normally occur to one skilled inthe art to which the invention relates.

The present application generally relates to an integrated samplingdevice that has two openings for the drawing of bodily fluids. Oneopening is operatively coupled to a channel to automatically draw fluidthrough the channel up to a test strip or other test media to analyzethe fluid. If the channel fails to draw a sufficient amount of fluid, asecond opening is provided directly opposite or to the side of the teststrip so the user may apply the sample fluid manually from the incisionsite through the second opening. The two openings insure that a teststrip is not wasted and a new incision does not have to be formed.

Referring now to FIG. 1, an integrated sampling device 30 according toone embodiment is illustrated. Overall, the flat design of device 30aids in improving the manufacturability of the device 30. Moreover, theflat design allows multiple sampling devices 30 to be connected togetherfor use in a cartridge, such as reel to reel type cartridge or a drum inan ACCU-CHEK® ADVANTAGE® brand meter (Roche Diagnostics Corporation,Indianapolis, Ind.). However, it should be appreciated that theintegrated sampling device 30 can have a different overall shape inother embodiments. For example, it is envisioned that the device 30 inother embodiments can be round or cylindrical in shape. The integratedsampling device 30 includes a connection portion 32 for connecting theintegrated sampling device 30 to a bodily fluid sampling device, asampling portion 34 for drawing fluid from the incision site up foranalysis, and an incision portion 36 for creating an incision in thebody part to be sampled. The integrated sampling device 30 asillustrated is designed to be used with a variety of bodily fluidsampling devices. Moreover, the integrated sampling device 30 in theillustrated embodiment is intended to be disposed after one use forsanitary reasons. It is contemplated, however, that in other embodimentsthe integrated sampling device 30 can be used multiple times aftersterilizing between uses. As shown, the connection portion 32 includes aconnection loop 38 that is separated from the sampling portion 34 bynotches 40. The notches 40 enable a firing mechanism of a bodily fluidsampling device to be attached to the integrated sampling device 30. Theconnection loop 38 defines a registration opening 42 that is designed toposition and secure the integrated sampling device 30 to the bodilyfluid sampling device.

The sampling portion 34 includes a body portion 44, spacer members 46, acapillary channel or cavity 48, a test media 50 and a collection sheet52. The body portion 44 provides a support for the remaining parts ofthe sampling portion 34 and allows all of the different parts to bemounted thereupon. The spacer members 46 define the channel 48 throughwhich fluid is drawn up to the test media 50 for testing. The collectionsheet 52 further assists in defining the channel 48.

In the illustrated embodiment, the body portion 44 is formed from ametal lancet. It is contemplated that in other embodiments the bodyportion 44 can be formed of a high-strength plastic, a compositematerial, a combination thereof, or other materials readily apparent toone skilled in the art. By being substantially flat, the body portion 44and other components can be easily formed from sheets of material, suchas metal or plastic, and these sheets can be sandwiched together inorder to mass produce body portions 44 and other components.Nonetheless, it should be appreciated that the body portion 44 can beshaped differently in alternate embodiments.

The spacer members 46 are made of plastic in the illustrated embodiment.It should be understood that the spacer members 46 can be formed fromother materials, such as a bead of adhesive or a piece of metal, to namea few. In one embodiment, the spacer members 46 are coated with anadhesive on one side to fix the spacer members 46 to the body portion44. In an alternate embodiment, the spacer members 46 are fixed to thebody portion 44 using adhesive tape. Moreover, it is contemplated thatthe spacer members 46 may be secured in other manners readily apparentto one skilled in the art. In other embodiments, the body portion 44 andthe spacer members 46 are directly attached to one another.

As shown, the channel 48 in the illustrated embodiment is arectangularly shaped passage. It is contemplated that in otherembodiments that this passage defines a different geometrical shape. Oneexample, among others, would be a passage that is cylindrical in nature.The dimensions of the channel 48 vary in differing embodiments. FIG. 1illustrates an embodiment where the channel 48 is sized to draw bodilyfluid via capillary action. Alternate embodiments contemplate drawingfluid in other manners, such as via a vacuum.

Referring to FIG. 1, the test media 50 in the illustrated embodiment islocated at the end of the channel 48 that is opposite the incisionportion 36. However, it should be understood that the test media 50 canbe located at difference locations along the channel 48. The test media50 is configured to determine analyte levels or other properties of thebody fluid sample. As should be appreciated, the properties of the bodyfluid sample can be determined through the chemical, electrical,electrochemical and/or optical properties of the bodily fluid samplecollected on the test media 50 to name a few. For example, the testmedia 50 is illustrated as a chemically reactive reagent test strip.Optionally, an absorbent pad may be placed between the test strip in theclosed end of the capillary channel 48 for wicking body fluid onto thetest media 50. The spreading or wicking layers ensure that the fluid isadsorbed uniformly across the surface of the test media 50. The uniformapplication of the fluid assists the test media 50 in functioningproperly. Fluid drains from the capillary into the wick material andspreads across the test media 50 for analysis. In one embodiment wherethe test media 50 is disposed within the capillary channel 48 noabsorbent pad may be needed because the test strip will be in directcontact with the body fluid. In one form, the bodily fluid is blood andthe property test is the level of glucose in the blood. Otherembodiments contemplate test media 50 that measure other qualities ofthe bodily fluid. One nonlimiting example would be the pH level of bloodor interstitial fluid.

As depicted in FIG. 1, the collection sheet 52 defines one side of thechannel 48. In the illustrated embodiment, the collection sheet 52 is asection of a clear plastic sheet. The collection sheet 52 is a flexiblesheet in the illustrated embodiment. By being flexible, the collectionsheet 52 is able to deform during lancing, and yet is able to contactthe skin without closing the incision in order to wick the fluid fromthe incision into the integrated sampling device 30. Moreover,collection sheet 52 provides a visual indicator such that the user cansee whether the integrated sampling device 30 is positioned close enoughto collect the fluid. In one particular form, collection sheet 52 is atransparent plastic film so as to allow the user to visualize theincision and the droplet of fluid during sampling. Other embodiments usedifferent materials and colors of material to form the collection sheet52. As should be appreciated, in other embodiments, the collection sheet52 can be semi-transparent and/or opaque. The collection sheet 52 has asampling end portion 53 that is configured to contact the skin duringsampling. The sampling end portion 53 flexes during collection of fluidso that only a minimal amount of force is applied to the skin such thatthe fluid flow from the incision is not restricted. In one embodiment,the flow of fluid may be enhanced by forming the spacer members 46 andthe collection sheet 52 out of a material that is hydrophilic, that hasbeen treated to be hydrophilic, or that has been coated with ahydrophilic material such as a surfactant or hydrophilic polymers. Thesurfaces can also be treated using polyamides, oxidation (e.g.corona/plasma treatment); plasma chemical vapor deposition; vacuum vapordeposition of metals, metaloxides or non-metaloxides; or deposition ofan element that oxidizes with water. In one form, the collection sheet52 also protects the test media 50 from external disrupting conditions.

With reference to FIG. 3, near the incision portion 36, the channel 48has a first opening 54 through which the body fluid enters the capillarychannel 48. By being located next to the incision portion 36, the firstopening 54 is able to automatically draw body fluid from the incision,once the incision is formed. As illustrated, the sampling end portion 53of the collection sheet 52 extends next to the first opening 54 suchthat the collection sheet 52 is able to assist in automatically drawingfluid into the first opening 54.

As mentioned before, the body portion 44 as well as the incision portion33 in the illustrated embodiment is made from a flat lancet. Asillustrated in FIG. 1, the incision portion 36 includes a blade support56 and a blade 58 for forming an incision in a body part. Further, thebody portion 44 includes a stop edge 60 at the end illustrated in FIG.3. The blade support 56 connects the blade 58 to the body portion 44,and the blade support 56 is shaped to spread the strain that is placedon the blade 58. As depicted, the blade support 56 converges inwards toeventually form the sides of the blade 58. The blade 58 is sharp so itcan form an incision in the skin, and the stop edge 60 can be used tolimit the penetration depth of the blade 58. However, other types ofmechanisms can be used to limit the penetration depth of the blade 58before the skin reaches the stop edge 60. In the illustrated embodiment,the blade 58 has a cross sectional shape that is rectangular, but theblade 58 can be shaped differently in other embodiments. For example,the blade 58 has a circular cross sectional shape in one embodiment, andthe blade 58 has a slanted shape in an alternate embodiment. Otherconfigurations of the blade 58 readily apparent to those skilled in theart are contemplated. Moreover, even though the blade 58 is shown asbeing fixed in position with respect to the rest of the device 30, itshould be appreciated that the blade 58 in other embodiments can bemoveable with respect to the rest of the device 30. Although theintegrated sampling device 30 in FIG. 1 uses the blade 58 to form anincision, it should be appreciated that the device 30 can incorporateother means for rupturing the skin, such as a laser.

Referring to FIG. 2, the body portion 44 of the integrated samplingdevice 30 includes a contact or expression surface 64 that defines asecond opening 66 for manually dosing onto the test media 50. In theillustrated embodiment, the second opening 66 is machined into a lancet,but it should be appreciated that the second opening can be formed inother ways, such as through photo-etching. The second opening in FIG. 2is generally circular in shape. However, the second opening can beshaped differently in other embodiments. As shown, the second opening 66is positioned over the test media 50 to ensure the body fluid isdirectly applied to the test media 50. By positioning the second opening66 directly over or near the test media 50, lesser amounts of fluid arerequired because the fluid does not have to fill the entire channel 48before being deposited onto the test media 50. Although the secondopening 66 in the illustrated embodiment is positioned directly over thetest media 50, it is contemplated that in alternative embodiments, thesecond opening 66 can be placed partially over the test media 50 or tothe side of the test media 50. When the body fluid is sampled throughthe first opening 54, the second opening 66 acts as a vent to vent airfrom the channel 48. In contrast, when fluid is sampled through thesecond opening 66, the first opening 54 can act as a vent. Nevertheless,it should be appreciated that vents can be formed at other locations inthe integrated sampling device 30. For instance, a vent can be formed bythe channel 48 at the end opposite the incision portion 36. To preventaccidental cuts, a protective cap 68 covers the blade 58, as is shown inFIG. 3. The protective cap 68 also ensures the sterility of the blade 58before it is used to form an incision.

A technique for sampling and analyzing body fluid with the integratedsampling device 30 will now be described with reference to FIGS. 4 and5. As noted above, the integrated sampling device 30 samples fluid intwo different ways. First, fluid is automatically sampled for analysisvia the first opening 54 of the channel 48. If an insufficient amount offluid is collected to allow analysis, the body fluid is then sampledmanually via the second opening 66. Before fluid is collected with thesecond opening 66, additional fluid can be expressed by pressing thesecond opening around the incision, if needed.

Before forming an incision, the integrated sampling device 30 isinstalled into a body fluid sampling device that is able to fire device30 into the skin to form an incision 72. In one embodiment, the bodypart in which the incision is formed is a finger, and in anotherembodiment, the body part is the forearm. It is contemplated, however,that fluid can be drawn from other body parts. Once fired the blade 58penetrates the skin to form the incision, and afterwards, the blade 58is retracted either fully or partially from the incision 72. Theintegrated sampling device 30 can be retracted from the incision 72either manually by the user, or automatically through a retractionmechanism, such as a spring. Furthermore, the user in other embodimentscan manually cut the skin with the blade 58 in order to form theincision. In the embodiment illustrated in FIG. 4, the blade 58 is fullyretracted from the incision 72 to allow bodily fluid 74 to flow from theincision 72.

After lancing, the integrated sampling device 30 is positioned proximalto the body part 70 in order to collect fluid 74 from the incision 72.As should be appreciated, the integrated sampling device 30 simplifiespositioning for collecting fluid 74. The integrated sampling device 30does not have to be reoriented or repositioned after lancing in order tocollect the fluid 74. Moreover, the collection sheet 52 provides avisual indicator to the user so as to ensure that the integratedsampling device 30 is positioned at the appropriate distance from thebody part 70 for drawing fluid 74 from the incision 72. As depicted, thecollection sheet 52 is longer than the blade 58 so that during fluidcollection the collection sheet 52 is able contact the body part 70. Inother embodiments, the collection sheet may be shorter than the blade oreven the same length as the blade. Due to its flexible nature, thecollection sheet 52 does not substantially compress the body part 70such that the fluid 74 flow from the incision 72 is not restricted. Inthe illustrated embodiment, the collection sheet 52 contacts the bodypart 70 when fluid 74 is drawn. However, it is contemplated that thecollection sheet 52 in other embodiments can be positioned slightly awayso as to not contact the body part 70, but still close enough to drawthe fluid 74. The hydrophilic qualities of the collection sheet 52enhance the fluid flow along the collection sheet 52 and into thechannel 48. As depicted in FIG. 4, body fluid 74 is drawn into thechannel 48 via the first opening 54, and the drawn fluid 74 istransported to the test media 50. The fluid 74 can then be analyzed withthe test media 50 in order to determine the desired property, such asselected analyte levels in the fluid 74.

Sometimes the amount of fluid 74 that bleeds (or is expressed) from theincision 72 is insufficient to fill the channel 48 such that the testmedia 50 is unable to provide accurate test results. By looking throughthe collection sheet 52, the user can visually determine whether or nota sufficient amount of fluid was drawn into the channel 48. In otherembodiments, the integrated sampling device 30 can incorporate sensors,such as electrodes, that detect the sufficiency of the fluid sample. Aspreviously mentioned, the integrated sampling device 30 incorporates thesecond opening 66, which allows a second opportunity for the body fluid74 to be dosed onto the test media 50. The body fluid 74 can be dosed asecond time after additional fluid 74 bleeds from the incision 72 and/orafter the user expresses additional fluid from the incision 72, eithermanually or automatically. For example, the user can press theexpression surface 64 against the body part 70 to force fluid out of theincision 72 and into the second opening 66. Since the second opening 66is positioned closer to the test media 50 as compared to the firstopening 54, the amount of fluid that must be drawn is significantlylower than the amount of fluid that has to be drawn up the channel 48.

FIG. 5 illustrates the integrated sampling device 30 during manualdosing of the fluid 74 through the second opening 66. Although dosingthe body fluid 74 via the second opening 66 will be described withrespect to manual dosing, it is contemplated that the dosing can alsooccur automatically. In the illustrated embodiment, the user detachesthe integrated sampling device 30 from the firing mechanism of the bodyfluid sampling device to sample fluid 74 via the second opening 66, butit should be understood that the device 30 can remain attached to thebody fluid sampling device before dosing through the second opening 66in other embodiments. The user can allow the body fluid 74 to naturallybleed from the incision 72 before sampling the fluid via the secondopening 66. Alternatively or additionally, to increase the amount ofbody fluid 74, the user can express additional body fluid 74 from theincision 72. In the illustrated embodiment, the user presses theexpression surface 64 that surrounds the second opening 66 around theincision 72. The manual compression of the body part 70, such as afinger, forces the body fluid 74 out of the incision 72 and into thesecond opening 66. The body fluid 74 is then directly deposited onto thetest media 50, and the test media 50 is then used to analyze the fluidsample.

An integrated sampling device 75 according to another embodiment isillustrated in FIG. 6. As shown, the sampling device 75 in FIG. 6 sharesa number of features in common with the one described above, such as thechannel 48, test media 50, collection sheet 52, first opening 54, andblade 58. However, instead of having a second opening formed in the bodyportion 44 of the sampling device 75, one of the spacers 46 defines asecond opening 76 through which body fluid 74 can be collected onto thetest media 50. In particular, the spacer 46 on the right lateral side ofthe sampling device 75, as viewed in FIG. 6, includes opposing spacerelements 78 that together define the second opening 76 along with thetest media 50 and the body portion 44. Similar to the previousembodiment, the spacers 46 further define a vent opening 80 for ventingair from the channel 48 at the end of the channel 48 opposite the firstopening 54. Although the second opening 76 is formed in the spacer 46 atthe right side in FIG. 6, it should be appreciated that the secondopening 76 can be formed in either lateral side or in both lateral sidesof the sampling device 75, however. Like before, the second opening 76can be used to manual dose fluid 74 onto the test media 50 if aninsufficient amount of fluid 74 is drawn via the first opening 54. Asdepicted, the sides of the second opening 76 are tapered so as tominimize dose hesitation when the fluid is sampled. In the illustratedembodiment, the second opening 76 is completely covered by the testmedia 50, but it is envisioned that the second opening 76 can be offsetfrom the test media 50 in other embodiments. By forming the secondopening 76 in one of the spacers 46, manufacturing of the integratedsampling device 75 can be simplified.

In the above described embodiments, only individual integrated samplingdevices were shown, but it should be appreciated that these samplingdevices can be incorporated into a drum or cassette such that multipleintegrated sampling devices can be used together. For example, multipleintegrated sampling devices 30 can be coupled together with a flexiblesheet 82 so as to form a belt or tape 84 that can be stored in areel-to-reel type cassette 86. Moreover, it is envisioned that thesecond opening can be formed at other locations on the integratedsampling device, and the sampling devices can include more than twoopenings through which fluid can be sampled. Although the integratedsampling devices in the drawings have two or more spacers, it should beunderstood that the sampling devices can include just a single spacer.

While the invention has been illustrated and described in detail in thedrawings and foregoing description, the same is to be considered asillustrative and not restrictive in character, it being understood thatonly the preferred embodiment has been shown and described and that allchanges and modifications that come within the spirit of the inventionare desired to be protected.

1. A method, comprising: securing at least two spacers to a lancet to atleast in part define a capillary channel with a first opening forcollecting body fluid; securing test media along the capillary channel;and forming a second opening for collecting body fluid with the at leasttwo spacers.
 2. The method of claim 1, further comprising: forming avent opening with the spacers at an end of the capillary channel that isopposite the first opening.
 3. The method of claim 1, furthercomprising: securing a fluid collection sheet to the at least twospacers.
 4. The method of claim 1, in which said securing the at leasttwo spacers includes fixing the at least two spacers to the lancet withadhesive.
 5. A method, comprising: creating a capillary channel along alancet, wherein the capillary channel has a first opening for collectingbody fluid and a vent opening at an end of the capillary channel that isopposite the first opening; positioning a test media along the capillarychannel between the first opening and the vent opening; and forming asecond opening along the capillary between the first opening and thevent opening, wherein the second opening is located closer to the testmedia than the first opening, wherein the first opening, the secondopening, and the vent opening are separate and distinct from oneanother.
 6. The method of claim 5, wherein said forming the secondopening includes forming the second opening in the lancet.
 7. The methodof claim 6, wherein said forming the second opening in the lancetincludes machining the second opening in the lancet.
 8. The method ofclaim 6, wherein said forming the second opening in the lancet includesphoto-etching the second opening in the lancet.
 9. The method of claim6, wherein said forming the second opening in the lancet includeslocating the second opening directly over the test media.
 10. The methodof claim 5, further comprising: wherein said creating the capillarychannel includes securing at least two spacers to the lancet to at leastin part define the capillary channel; and wherein said forming thesecond opening includes forming the second opening in at least one ofthe at least two spacers.
 11. The method of claim 10, furthercomprising: securing a hydrophilic fluid collection sheet to the atleast two spacers.
 12. The method of claim 10, wherein said forming thesecond opening includes tapering the second opening to reduce dosehesitation.
 13. The method of claim 5, wherein said creating thecapillary channel includes covering the capillary channel with ahydrophilic fluid collection sheet that extends from the first opening.14. The method of claim 5, further comprising wherein said forming thesecond opening includes forming the second opening in the lancet;wherein said forming the second opening in the lancet includes locatingthe second opening directly over the test media; and wherein saidcreating the capillary channel includes covering the capillary channelwith a hydrophilic fluid collection sheet that extends from the firstopening.
 15. The method of claim 5, further comprising: wherein saidcreating the capillary channel includes securing at least two spacers tothe lancet to at least in part define the capillary channel; whereinsaid forming the second opening includes forming the second opening inat least one of the at least two spacers; securing a hydrophilic fluidcollection sheet to the at least two spacers; and wherein said formingthe second opening includes tapering the second opening to reduce dosehesitation.